K250010
- 510(k) number
- K250010
- Device name
- EXTRON 3; EXTRON 5; EXTRON 7
- Applicant
- DRTECH Corporation KR
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2025-06-10
- Date received
- 2025-01-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250010.pdf
Official FDA record: K250010
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.